Manufacturing consumer devices is hard enough. Issues involving cost, turnaround, suppliers, labor, transport and more are a constant presence. And, with nationalism and other political agendas, it is not hard to see why many companies and their systems are unable to keep pace. But when the products being manufactured are precision medical devices where human life is involved, then the challenges become far greater.
For one thing, there is a level of regulation by federal agencies that is far more stringent than most consumer goods will ever face. The FDA’s Quality System Regulation requires medical device makers to establish and maintain device history records (DHRs) to document every batch, lot and unit they produce. No longer can this be effectively accomplished when relying upon paper-based or manual processes.
It is Time to Simplify the Complex
Every step in the operation of producing a finished medical device needs to be recorded. That includes the people who worked on it, their certifications, what parts and tools were used, and what tests were performed (see the full list from 21 CFR Part 820). Then, as you get to the end of the process, a quality inspector steps in and spends hours reviewing the DHRs to make sure every shred of paper that needs to be in place is accounted for. If something is amiss, the unit doesn’t get shipped.
Of course, this is not some sort of sinister plot to drive device makers insane. It is a conscientious effort to make sure equipment used to protect the lives of people, including many who are critically ill, is as reliable and effective as possible. In a worst-case scenario, a serious product defect could lead to a patient’s death. And that would carry grave consequences for everyone involved in the patient’s care, particularly including the device’s manufacturer.
What Has Changed Today
The process of creating the required DHR documentation, which is still often done by hand, is tedious, time-consuming and prone to errors. More importantly, the information collected is seldom available to readily share with others for future product and process improvement. The real value of migrating over to a digital information collection and distribution strategy is the collection, analysis, and real-time decision support enabled from all the valuable intelligence that is now available. This value is completely lost in a paper-based, manual DHR process.
Leading medical device manufacturers have discovered that the implementation of a modern manufacturing execution system (MES) is an ideal hub to implement and manage their digital strategy. And, it can be a great way to streamline the transition to a digital DHR strategy, also referred to as an Electronic DHR or eDHR.
This type of approach can operate as an integral component of how operations are managed and steadily improved upon over time. Under the MES umbrella, there are software applications for production management, performance analysis, quality assurance, compliance and human-machine interface. And, with access to all the necessary digital data to complete regulatory requirements and approval, the benefits of pursuing such a strategy can add up quickly.
We Do Not Live in A One-Size-Fits-All Environment
No single solution can manage every aspect of manufacturing, quality, supply chain, inventory, purchasing and distribution management. But that is ok. In a digital world with standardized APIs, multiple applications can work seamlessly together across the digital enterprise with far greater efficiency and performance than a legacy, single-vendor solution with hard-coded interfaces that are difficult to implement and maintain.
Market demands are now encouraging the expansion of MES capabilities, gradually filling in the gaps in end-user needs. An eDHR is just one of the positive outcomes. Other needs driving this adoption with medical device manufacturers include:
- Reducing the cost of maintaining quality
- Providing accurate and timely information to meet compliance requirements
- Meeting the accelerating demands of new product introduction and frequent engineering changes
- Maintaining scheduled production commitments
- Continuous improvement of the company’s products
Of course, many types of enterprise software should be part of a medical device manufacturer’s overall digital application footprint. These include enterprise resource planning (ERP), product lifecycle management (PLM), and quality management systems (QMS), each of which is already widely used.
It can be tempting to think of these applications doing the work of an MES already. But ERPs perform best as a system of record-to-record transactions, manage costs, and provide an account of profitability at the end of the day. This type of system is not well suited to managing the day-to-day operations of an MES to meet the production and intelligence gathering requirements of medical device makers. Nor can it be your primary source of intelligence to migrate over to an eDHR program. Further, as ERP is typically owned and managed by the finance and IT departments, it is difficult to control your destiny when another department manages the budget.
By the same token, QMSs tend to be heavily document-centric. When you aggregate the time spent creating, distributing and filing all the associated documents, the time lost due to their misplacement, the errors from manual keystrokes, and the repetitive information entry, QMSs tend to be staff and time-intensive. Beyond that, they are not created or available in real-time. Most importantly, these types of systems can’t do what an MES system does. It should come as no surprise that a QMS on its own won’t help much in gathering all the data necessary to go digital with your eDHR compliance strategy.
The Path Forward
What should be clear is that the role of an MES has transformed into becoming an integral part of every manufacturer’s digital arsenal. As your primary source of data to validate and confirm production processes were completed according to plan, it thereby ensures the right intelligence is available for eDHR.
The intelligence now available for extraction across a production environment has increased exponentially over the past few years. This knowledge is now leading to significant product and process improvement opportunities—concepts that were unimaginable just 10 years ago. It is also leading to a way to simplify complex audits and regulatory compliance reviews, helping to keep the quality high and cost low for medical device manufacturers.
Not only can an MES be the primary source for future improvement and product innovation, but it can also drive down the five biggest categories of waste in the production of medical devices as part of a strategy to remove manual and paper processes. This includes the reduction of non-value indirect labor; reduction of scrap, rework, and obsolescence; reduction of direct labor costs; reduction of warranty costs; and reduction of paper storage costs. It all adds up.
If you want to take advantage of all the potential benefits of today’s digital world, then the first step you need to embrace is how best to leverage your MES to be the lynchpin of your data collection and distribution model. Use this model to then help drive eDHR adoption to add further ROI to your MES investment. Add in the potential for cost savings and other benefits, and it is easy to see why medical device manufacturers are increasingly investing in or upgrading their MES footprint. By helping to make the complexity of medical device manufacturing simpler, more productive, and with greater profitability, you may decide that an MES has never looked so good.